"The U.S. Food and Drug Administration plans to change how COVID vaccines and other shots are approved and administered. In a memo obtained by the New York Times and other outlets, a top FDA official directly linked the deaths of 10 children to COVID vaccines but included scant details about the cases, including the specific vaccine in question or how the FDA came to its conclusions."
"The proposals include requiring vaccine makers to study new shots in all subgroups (including pregnant people), changing how the annual flu shot is approved and reconsidering whether the flu and COVID shots can be gotten together. Collectively, the changes would require vaccine makers to show far more data on safety and efficacy, driving up costs and ultimately making childhood vaccinations less accessible, experts say."
A leaked FDA memo links 10 child deaths to COVID vaccines but provides few details about the cases or how conclusions were reached. The memo proposes stricter testing and approval requirements, including studies in all subgroups such as pregnant people, changes to annual flu shot approval, and reevaluation of co-administration of flu and COVID vaccines. Experts criticize the proposals as not science-based and warn that requiring substantially more safety and efficacy data will raise costs, complicate schedules, delay access to protective vaccines, and make childhood vaccinations less accessible. Regulators continue to weigh rare risks against vaccine benefits.
Read at www.scientificamerican.com
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